CONSTRUX - MINI PEEK VBR

GUDID 18257200042142

CONSTRUX MINI 7MM H X 15MM W X 12MM L - 5DEG LORDOTIC

ORTHOFIX INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 18257200042142
• NIH Device Record Key: d7c74a2f-cf41-4ab6-bd80-e73008814405
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSTRUX - MINI PEEK VBR
• Version Model Number: 47-4007
• Company DUNS: 927083808
• Company Name: ORTHOFIX INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200042142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172437

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

[18257200042142]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-03-19

On-Brand Devices [CONSTRUX - MINI PEEK VBR]

• 18257200135813: IMPLANT INSERTER ASSEMBLY
• 18257200082957: CONSTRUX MINI PEEK SPACER SYSTEM - INSTRUMENT KIT (47-0012)
• 18257200081370: CONSTRUX MINI, SPACER AND VBR SYSTEMS (47-0010)
• 18257200042357: CONSTRUX MINI 15MM W X 12MM D X 14MM H, PARALLEL
• 18257200042340: CONSTRUX MINI 14MM H X 15MM W X 12MM L - PARALLEL
• 18257200042333: CONSTRUX MINI 15MM W X 12MM D X 13MM H, PARALLEL
• 18257200042326: CONSTRUX MINI 13MM H X 15MM W X 12MM L - PARALLEL
• 18257200042319: CONSTRUX MINI 12MM H X 15MM W X 12MM L - PARALLEL
• 18257200042302: CONSTRUX MINI 11MM H X 15MM W X 12MM L - PARALLEL
• 18257200042296: CONSTRUX MINI 10MM H X 15MM W X 12MM L - PARALLEL
• 18257200042289: CONSTRUX MINI 9MM H X 15MM W X 12MM L - PARALLEL
• 18257200042272: CONSTRUX MINI 8MM H X 15MM W X 12MM L - PARALLEL
• 18257200042265: CONSTRUX MINI 7MM H X 15MM W X 12MM L - PARALLEL
• 18257200042258: CONSTRUX MINI 6MM H X 15MM W X 12MM L - PARALLEL
• 18257200042241: CONSTRUX MINI 5MM H X 15MM W X 12MM L - PARALLEL
• 18257200042234: CONSTRUX MINI 15MM W X 12MM D X 14MM H, 5? LORDOTIC
• 18257200042227: CONSTRUX MINI 14MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042210: CONSTRUX MINI 15MM W X 12MM D X 13MM H, 5? LORDOTIC
• 18257200042203: CONSTRUX MINI 13MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042197: CONSTRUX MINI 12MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042180: CONSTRUX MINI 11MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042173: CONSTRUX MINI 10MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042166: CONSTRUX MINI 9MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042159: CONSTRUX MINI 8MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042142: CONSTRUX MINI 7MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042135: CONSTRUX MINI 6MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042128: CONSTRUX MINI 5MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042111: CONSTRUX MINI 12MM W X 12MM D X 14MM H, PARALLEL
• 18257200042104: CONSTRUX MINI 14MM H X 12MM W X 12MM L - PARALLEL
• 18257200042098: CONSTRUX MINI 12MM W X 12MM D X 13MM H, PARALLEL
• 18257200042081: CONSTRUX MINI 13MM H X 12MM W X 12MM L - PARALLEL
• 18257200042074: CONSTRUX MINI 12MM H X 12MM W X 12MM L - PARALLEL
• 18257200042067: CONSTRUX MINI 11MM H X 12MM W X 12MM L - PARALLEL
• 18257200042050: CONSTRUX MINI 10MM H X 12MM W X 12MM L - PARALLEL
• 18257200042043: CONSTRUX MINI 9MM H X 12MM W X 12MM L - PARALLEL
• 18257200042036: CONSTRUX MINI 8MM H X 12MM W X 12MM L - PARALLEL
• 18257200042029: CONSTRUX MINI 7MM H X 12MM W X 12MM L - PARALLEL
• 18257200042012: CONSTRUX MINI 6MM H X 12MM W X 12MM L - PARALLEL
• 18257200042005: CONSTRUX MINI 5MM H X 12MM W X 12MM L - PARALLEL
• 18257200041992: CONSTRUX MINI 12MM W X 12MM D X 14MM H, 5? LORDOTIC
• 18257200041985: CONSTRUX MINI 14MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041978: CONSTRUX MINI 12MM W X 12MM D X 13MM H, 5? LORDOTIC
• 18257200041961: CONSTRUX MINI 13MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041954: CONSTRUX MINI 12MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041947: CONSTRUX MINI 11MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041930: CONSTRUX MINI 10MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041923: CONSTRUX MINI 9MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041916: CONSTRUX MINI 8MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041909: CONSTRUX MINI 7MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041893: CONSTRUX MINI 6MM H X 12MM W X 12MM L - 5DEG LORDOTIC